Kornimate/medical-research-clean huggingface dataset:
prolonged nightly fasting in fibromyalgia

Conditions: Fibromyalgia

Summary: the present randomized-controlled pilot trial will test the feasibility, acceptability, and preliminary efficacy of an 8-week prolonged nightly fasting (pnf) intervention protocol in 20 adults with fibromyalgia. aim 1: evaluate feasibility and acceptability of the pnf intervention among participants with fibromyalgia. aim 2: evaluate preliminary efficacy of pnf on pain severity and sensitivity, mood, sleep and inflammation.

fibromyalgia is characterized by chronic widespread pain, sleep disturbance, fatigue, negative mood, and cognitive dysfunction. it is estimated about 4 million individuals in the u.s. are affected by fibromyalgia, which results in high disability, lost productivity, and poor quality of life. various medications have been tested, but findings suggest only small therapeutic effects with high side effects. first line evidence-based psychosocial interventions, such as cognitive behavioral therapy, also yield only small to moderate treatment effects and they require specialized personnel. thus, there is a dire need to develop a novel approach to manage fibromyalgia symptoms with a high safety profile, are affordable, and are easily implemented by participants without extensive guidance and support from specialized personnel. prolonged nightly fasting (pnf) which is a type of time-restricted eating with no or minimal caloric intake for periods of time as few as 12 hours has been shown to promote various health benefits. pnf has also been demonstrated to be highly acceptable and adherable for adults with various clinical condition. although some dietary patterns have been explored for their impact on pain, the effects of pnf on pain-related outcomes (e.g., pain severity, pain sensitivity), mood, sleep, and inflammation among individuals with fibromyalgia have not been examined. the present randomized-controlled pilot trial will test the feasibility, acceptability, and preliminary efficacy of an 8-week pnf intervention protocol in 20 adults with fibromyalgia.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 * female * able to speak, write, and read english * classified as having fibromyalgia based upon criteria established by the most up-to-date 2016 american college of rheumatology (acr) criteria for fibromyalgia * has a smartphone. exclusion criteria: * history of eating disorders assessed by mini neuropsychiatric interview * self-report of chronic malignant pain (e.g., cancer, hiv) or systemic inflammatory disease (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus) * current use of melatonin or an immunosuppressant medication (e.g., steroids) * currently pregnant, trying to get pregnant, or breastfeeding * plans to relocate within the next 6 months * has diabetes mellitus * currently trying to lose weight * currently routinely fasting more than 12 hours a night * works night shifts

Keywords: intermittent fasting chronic pain quantitative sensory testing sleep
etoricoxib versus gabapentin for knee arthroscopy

Conditions: Knee Arthroscopy

Summary: to determine that when administered as part of a multimodal analgesic regimen, use of the new cox-2 antagonist etoricoxib (120 mg/day, per os) is more effective in improving postoperative pain management after knee arthroscopy than gabapentin (1.2 g/day, per os).

background: post-discharge pain remains a significant problem after many ambulatory surgery procedures. both etoricoxib and gabapentin have been used to prevent postoperative pain; however their relative efficacy in the post-discharge period is not known. we hypothesized that daily use of etoricoxib would offer advantages over gabapentin as part of a multimodal analgesic regimen in the perioperative period due to its pharmacokinetic profile. methods: seventy-five healthy outpatients undergoing elective ambulatory knee arthroscopy were randomly assigned to receive identical-appearing capsules containing either a placebo, gabapentin (1.2g, or etoricoxib 120 mg, 30-90 min before skin incision and at 08h00 on the first, second, and third postoperative days. post-discharge pain was treated with "rescue" dipyrone syrup (500 mg). pain intensity (as assessed using a 100 visual analog scale), dipyrone usage, and the incidence of nausea and vomiting, sedation and anxiety were recorded at specific time intervals in the postoperative period. the recovery of functional activity was assessed at 96 h after surgery using a validated questionnaire.

Eligibility criteria:
inclusion criteria: * elective ambulatory knee arthroscopy exclusion criteria: * history of clinically-significant cardiovascular,pulmonary,hepatic,renal, neurologic, psychiatric or metabolic disease * patients chronically receiving pain killers

Keywords: post-operative pain knee arthroscopy gabapentin etoricoxib elective ambulatory knee arthroscopy
moderately hypofractionated conformal radiation combined with s-1 for esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this phase ii randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined with s-1 for esophageal squamous cell carcinoma.

this phase ii randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined with s-1 for esophageal squamous cell carcinoma. all patients will receive two cycles of s-1 (40mg/㎡, bid, po) on d1-14, d22-35, combined with thoracic radiotherapy of 60 gy/24 fractions for gtv and 40 gy/16 fractions for ctv. the primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date on which disease progresses. progression-free survival will be calculated and compared using the kaplan-meier method.toxicities will be graded according to ctcae v. 4.0.

Eligibility criteria:
inclusion criteria: * histologically confirmed esophageal squamous cell carcinoma * inoperable stage ii-iva (uicc 2002; sixth edition), confirmed by contrast enhanced computed tomography,endoscopic ultrasonography, barium esophagram, emission computed tomography and/or positron emission tomography/computed tomography. * eastern cooperative oncology group (ecog) performance status 1-2 * estimated life expectancy of at least 12 weeks * charlson comorbidity index.4 * adequate bone marrow function: white blood cells grade 0 or 1,absolute neutrophils grade 0 or 1, platelets grade 0, haemoglobin grade 0 or 1 * adequate renal function: creatinine grade 0 or 1 * adequate liver function: serum bilirubin grade 0 or 1, alanine aminotransferase and aspartate aminotransferase \<2 times of the upper normal limit * weight loss.15% during 6 months prior to diagnosis * forced expiratory volume second.1l exclusion criteria: * prior history of malignancy, except for nonmelanoma skin carcinoma or cervical carcinoma in situ * previous anti-tumor therapy, including surgery, chemotherapy or radiotherapy * contraindication for chemotherapy or radiotherapy * malignant pleural or pericardial effusion * women in pregnancy or lactation period * women who has the probability of pregnancy without contraception * weight loss≥15% during 3 months prior to diagnosis * in other clinical trials within 30 days * addicted in drugs or alcohol, aids patients * uncontrollable seizure or psychotic patients without self-control ability * severe allergy or idiosyncrasy * not suitable for this study judged by researchers

Keywords: esophageal squamous cell carcinoma hypofractionated conformal radiation s-1
efficacy and safety of hgp1910 and hcp1903 in patients with primary hypercholesterolemia

Conditions: Primary Hypercholesterolemia

Summary: the purpose of this study is to investigate the safety and clinical efficacy of hgp1910 and hcp1903 in patients with primary hypercholesterolemia


Eligibility criteria:
inclusion criteria: * participants aged ≥ 19 years * participants who have voluntarily given written consent to participate in this clinical trial * participants with ldl-c ≤ 250mg/dl and tg \< 500mg/dl at visit 1 * participants with ldl-c ≤ 250mg/dl, tg \< 500 mg/dl and satisfied criteria according to cardiovascular risk category at visit 2 (after at least 4 weeks of tlc) exclusion criteria: * patients with active liver disease and severe liver impairment * patients with severe renal failure (egfr \< 30 ml/min/1.73 m2 at visit 1) * patients with type i diabetes or uncontrolled type 2 diabetes * patients with acute hypertension or uncontrolled hypertension (sitsbp ≥ 180 mmhg or sitdbp ≥ 110 mmhg at visit 1) * patients with symptomatic orthostatic hypotension * patients with nyha class iii\~iv heart failure, ccsa class iii\~iv angina, ventricular arrhythmia, severe hemorrhagic or ischemic cerebrovascular diseases, transient ischemic attacks (tias), acute coronary syndrome or a history of angioplasty, percutaneous coronary intervention, or coronary artery bypass surgery within six months before visit 1. * patients who were diagnosed with a malignant tumor within five years before visit.
evaluation for the characterization of the safety profile of the diamondtemp™ system for fast treatment of patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the objective of this study is to characterize the performance of the diamondtemp ablation system for its intended use.

* the diamondtemp ablation system is indicated for use in patients requiring cardiac electrophysiological mapping (stimulation and recording) and, when used in conjunction with a radiofrequency generator and irrigation pump, for cardiac ablation with monitoring of tissue temperature during ablation. * in this study, the diamondtemp ablation system will be evaluated for the treatment of patients with atrial fibrillation.

Eligibility criteria:
inclusion criteria: * suitable candidate for intra-cardiac mapping and ablation for arrhythmias * history of recurrent symptomatic paf with ≥2 episodes reported within the 365 days * (12) months prior to enrollment * at least 1 episode of af documented by holter monitor, rhythm strip, trans-telephonic monitor (ttm), or 12-lead ecg prior to enrollment * refractory to at least one class i-iv anti-arrhythmic drug (aad) * eighteen (18) years of age or above exclusion criteria: * previous left atrial ablation procedure * intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement * known severe cerebrovascular disease or history of cerebrovascular event (\< 1 month) * subjects with severely impaired kidney function as measured by a cockcroft-gault glomerular filtration rate (gfr)3 with a gfr ≤ 29. active gastrointestinal bleeding * active infection or fever (\>100.5 f/38 ◦c) * sepsis * cardiac surgery within the past two months. * short life expectancy (\<1 yr.) due to other illnesses, such as cancer or pulmonary, hepatic, or renal disease significant anemia (hemoglobin \< 8.0 mg/dl) * severe uncontrolled systemic hypertension (systolic pressure \> 240 mm hg within the last 30 days) * documented anaphylaxis during previous exposure to angiographic contrast media * uncontrolled congestive heart failure (nyha1 class iii or iv) * unstable angina or acute myocardial infarction within the past three months * bleeding, clotting disorders, or known thrombosis * severe peripheral vascular disease * uncontrolled diabetes * heart valve replacement * mitral clip (e-valve) * women who are of childbearing potential who are currently pregnant or not willing to use contraception for the duration of the study * active participation in another investigational protocol currently or the last 30 days * unable or unwilling to take anti-coagulants * unwilling or unable to comply with any protocol or follow up requirements
effects of cognitive behavior language therapy for patients with post stroke aphasia

Conditions: Aphasia

Summary: this study is clinical trial based and the target population in this study is patients with post-stroke aphasia. cognitive linguistic quick test (clqt) and speech language unhelpful thoughts and belief scale (slutbs) will apply as an assessment. inclusive criteria include diagnosed male and female post-stroke severe aphasia patients above 30 years of age. these participants must have high instance of unhelpful speech language thoughts and belief. participants in inclusive criteria must not be participated in any other psychotherapy/ speech language intervention program. participants must sign an informed consent form. participants having a caregiver who is willing to be present during the period of intervention. exclusive criteria include individuals below 30 years of age and patients with aphasia caused by non-stroke etiology. the aim of the study is to check the effects of cognitive behavior language therapy on patients with post-stroke aphasia. so, it will help speech language pathologists to adopt the principles of cblt intervention to treat aphasia that occurs as a result of aphasia.


Eligibility criteria:
inclusion criteria: * both male and female. * over 30 years of age. * all types of diagnosed aphasia. * severe aphasia following stroke. * high instance of unhelpful speech language thoughts and belief. * participants who are not participating in any other psychotherapy / speech language intervention program will be included. * participants who are willing to sign an informed consent form. * participants having a caregiver who is willing to be present during the period of intervention. exclusion criteria: * below 30 years of age. * patients with aphasia caused by a non-stroke etiology.
effect of tonsillar pillar closure on postoperative pain and bleeding risk after tonsillectomy

Conditions: Hemorrhage; Pain

Summary: the purpose of this study is to determine if closing the tonsil fossa after tonsillectomy leads to less pain and bleeding risk than leaving it open to heal by secondary intention.

after induction of appropriate general anesthesia, a tonsillectomy was performed and control of bleeding was achieved as is routine for the individual otolaryngologist performing the procedure. next the surgeon used 3-0 chromic (absorbable) sutures on tapered needles to close one tonsillar fossa but leave the tonsillar fossa on the other side open. the side chosen was determined by a computer generated schedule. routine postoperative care was given.

Eligibility criteria:
inclusion criteria: * any patient for whom tonsillectomy is recommended for recurrent pharyngitis, obstructive sleep disorder, snoring, halitosis, feeding difficulty associated with adenotonsillar hypertrophy, and who in the investigator's opinion, is capable of providing reliable responses to post-operative follow-up questions as defined in this protocol. exclusion criteria: * any patient for whom tonsillectomy is recommended for suspected malignancy or active peritonsillar abscess

Keywords: tonsillectomy suturing of tonsillar pillars pain postoperative hemorrhage, bleeding
budesonide for eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: eosinophilic esophagitis (ee) is a chronic, t-helper 2 cell (th2) - type inflammatory disorder of the esophagus with a rapidly increasing prevalence. studies analyzing the natural course of ee provide strong evidence, that the chronic inflammation leads to irreversible structural changes in the esophagus with a loss of the mucosal elasticity and a fibrosis of the sub-epithelial esophageal layers with a concomitant risk of impairment in function. treatment strategies in chronic inflammations have, in general, two main goals: 1) relief of symptoms and 2) prevention of long-term damage of the affected organ. until now, the treatment of ee is still controversial. standard recommendations for therapy of this chronic eosinophilic inflammation include dilation, systemic or topical corticosteroids and leukotriene antagonists. several of these reports demonstrate, that topical corticosteroids may be effective for symptom control as well as for down-regulating the local inflammation. furthermore it has been demonstrated, that treatment with topical corticosteroids is as effective as oral prednisone. however, the majority of therapeutic recommendations are based on clinical observations, case reports or small case series. the purpose of this study is the evaluation of the efficacy and the safety of a monotherapy with a topical corticosteroid as short-term induction-treatment and as long-term, maintenance-treatment compared with placebo, in the treatment of adult patients with active ee.

a randomized, double-blind, placebo-controlled, single center clinical trial to evaluate the efficacy and safety of topically applied budesonide in the treatment of adult patients with eosinophilic esophagitis.

Eligibility criteria:
inclusion criteria: * isolated eosinophilic esophagitis * adult patients (age \> 14 years) * active disease (clinically and histologically) * informed consent exclusion criteria: * current use of specific treatments for ee * secondary causes of esophageal eosinophilia * intolerance to budesonide * concomitant therapies for any reason that may affect assessment * use of an investigational drug with 30 days of entering the study * recent history or suspicion of current drug abuse and alcohol abuse * positive serum pregnancy test at the screening visit * any unstable serious co-existing medical condition

Keywords: eosinophilic esophagitis budesonide
study evaluating the success rate of outpatient management of the total benign hysterectomy by transvaginal natural orifice transluminal endoscopic surgery (vnotes) compared to each of the two laparoscopic routes (conventional and robot-assisted).

Conditions: Surgery; Gynecologic Disease

Summary: benign total hysterectomy is one of the most commonly performed gynecological surgery. conventionally performed by a classical surgical approach, it is now provided routinely and for several years by laparoscopy and more recently by robotic-assisted laparoscopy. a third minimally invasive option is currently being developed and proposed to avoid trans-peritoneal access, using a vaginal trans-laparoscopic technique, defined by the name v-notes (vaginal-natural orifice transluminal endoscopic surgery). these minimally invasive approaches have simplified this intervention on many surgical and anesthetic parameters (signing, surgical trauma, pain and post-operative ileus, recovery of autonomy) and consider possible management in the outpatient sector. this study aims at enrolling women for which a total hysterectomy with or without annexectomy for the treatment of a benign pathology must be scheduled. the objective of the study is to compare the success rate of outpatient treatment of the v-notes route and the conventional laparoscopic route and to compare the success rate of outpatient treatment of the v-notes route and the laparoscopic route assisted robot.


Eligibility criteria:
inclusion criteria: * participant aged 18 years old and over * participant for whom a total hysterectomy with or without adnexectomy for the treatment of a benign pathology must be scheduled * participant with no contraindication to being operated on by one of the three approaches under study (conventional laparoscopy, v-notes, robot-assisted laparoscopy) * patient eligible for outpatient treatment * participant affiliated or beneficiary of a social security regimen * participant having been informed and having given her free, informed and written consent (at the latest on the day of inclusion and before any examination required by the research) exclusion criteria: * participant with endometriosis with procedure associated with hysterectomy (digestive procedure, extended adhesiolysis, or other procedure) * participant whose physical and/or psychological health is severely impaired, which according to the investigator may affect the participant's understanding and compliance with the study * participant in another research * participant in a period of exclusion from another research still in progress at the time of inclusion * protected participant: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision * patient hospitalized without consent

Keywords: hysterectomy vnotes laparoscopy
colonoscope passive bending function

Conditions: Colitis; Adenoma; Carcinoma; Functional Colonic Disease

Summary: a prototype colonoscope with an extra passively bending distal section has been developed by olympus japan (ref. publications). the present study (2006-2007) is testing refinements of this function.

results from the first prototype evaluation has been published.modifications are presently evaluated.

Eligibility criteria:
inclusion criteria: * patients referred for routine outpatients colonoscopy exclusion criteria: * pregnant women * age below 18 years
exhaled hydrogen peroxide as a marker of lung disease study - conformité européenne (european conformity)

Conditions: Point of Care Monitoring

Summary: this study is designed to test whether the inflammacheck™ device is easy to use by healthcare professionals who would be using it in a clinic setting or in primary care. the data collected during this study will be used as part of the evidence needed to get the ce (conformité européenne) marking for the device. ce marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the european economic area (eea). ce marking is essential for any medical devices used in the uk or the eu.

this observational study has been designed to evaluate the ability of healthcare providers to use the inflammacheck™, an investigational medical device, to measure participants exhaled breath condensate (ebc) h2o2. the data will be used to support the ce marking of the inflammacheck™ device. a measure of the participants' ebc h2o2 will be measured on the inflammacheck™ device to demonstrate usability and comprehension of the instructions for use. there are no control measurements involved in the study, all of the participants' ebc h2o2 measurements will be performed using inflammacheck™ only. only healthcare providers naïve to the inflammacheck™ device will be eligible to take part in the assessment of usability. this is to ensure that the usability assessment will not be biased by prior knowledge of the device or its instructions. the only training provided will be an introductory presentation explaining the clinical investigation objectives. the total time for participant involvement is one session comprising of: * information \& consent * ebc h2o2 measurement with inflammacheck™

Eligibility criteria:
inclusion criteria: * male or female, aged 18 years or above. * member of nhs staff at pht. * is a healthcare provider. * participant is willing and able to give informed consent for participation in the study. exclusion criteria: * in the opinion of the clinical investigator, participant could be put at risk of harm by having to perform any of the study procedures. * unable to comprehend the study and provide informed consent e.g. insufficient command of english in the absence of someone to adequately interpret.